Staphylococcus AureusNCT01127516
The Causes and Interpretation of Low-level Resistance in Staphylococcus Aureus
An observational study of Staphylococcus Aureus, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The hypothesis of this investigation is that rate of isolation of resistant nosocomial pathogens can be explained by a combination of measures that include, among other things, antimicrobial drug use, infection control efforts, patient mix and antimicrobial stewardship efforts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inpatients
Who may be able to join
- Adult inpatients
Who cannot join
- Pediatric inpatients
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University School ofPharamcy
Richmond, Virginia, 23298
About this study
Official title: The Causes and Interpretation of Low-level Resistance in Staphylococcus Aureus to Vancomycin Among a Network of Academic Medical Center Hospitals
The hypothesis of this investigation is that rate of isolation of resistant nosocomial pathogens can be explained by a combination of measures that include, among other things, antimicrobial drug use, infection control efforts, patient mix and antimicrobial stewardship efforts. The short term goal of this investigation is to improve our understanding of the relationships between antimicrobial stewardship program efforts (and actual antimicrobial drug use), and infection control efforts to the incidence rates of MSSA, MRSA, h-VISA and SA-MICcreep. The long term goal of this investigation is to design interventions that will improve antimicrobial drug use and decrease cross-transmission of resistant bacteria, resulting in a decrease in the rates of infection caused resistant hospital organisms.
Read the detailed description
Study Design
We propose to survey clinical pharmacists, infectious diseases practitioners and clinical microbiologists at these 53 hospitals during the summer of 2009 to characterize the hospital policy toward isolation of SA-MICcreep and to investigate the relationship of SA-MICcreep to vancomycin use. Specifically, we will determine (1) if the hospital attempts to isolate SA-MICcreep (2) the method(s) of testing SA susceptibility to vancomycin, (3) interpretative criteria for MICs to vancomycin and whether there is a policy toward differential treatment of isolated with SA-MICcreep. In addition we will determine (1) the relationship of SA-MICcreep to vancomycin use and (2) the relationship to other hospital and patient demographics to SA-MICcreep. A pilot study (Dec. 2008) found that 7 of 8 hospitals surveyed do determine the vancomycin MIC for Staphylococcus aureus. However the interpretation of these findings, and the action taken, differ between hospitals. This may be because this is a newly described phenomenon, and professional organizations have not yet issued guidelines regarding the interpretation of these isolates (6).
We have measured vancomycin use by the following methods at each hospital:
- Days of therapy/1000 patient days.
- Mean duration of vancomycin therapy (days).
- Proportion of adult patients who receive vancomycin (%).
- Vancomycin "Intensity Index": The product of #2 and #3.
We will also measure the use of other antibacterial drugs that are used to treat infections caused by Staphylococcus aureus including linezolid and daptomycin as these drugs may reduce the isolation of SA-MICcreep.
The survey instrument will include requests for the following information:
- Does the clinical microbiology laboratory make an attempt to identify MIC creep for clinical isolates of Staphylococcus aureus?
- If yes, when did this policy begin?
- Are all Staphylococcus aureus isolates tested (i.e., MSSA and MRSA) or only MRSA?
- Are all clinical isolated routinely tested, or only selected isolates (e.g., only by request from ID, or only blood isolates, or only isolates from ICU patients, etc.)
- What method(s) is used to determine the MIC to vancomycin?
- What MIC is thought to warrant concern? (e.g., 1.0, 1.5, 2.0 mcg/ml) ?
- What action, if any, is taken as a function of the MIC to vancomycin?
- Is "more aggressive" therapy with vancomycin attempted if an isolate of concern is identified, or is alternative therapy recommended or routinely implemented?
- If alternative therapy is routinely administered, what is that therapy?
- Conditions
- Staphylococcus Aureus
- Keywords
- Susceptibility testing, Antimicrobial stewardship
- Medical subject headings
- Staphylococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of hospitals that test for MIC creep to vancomycin
Survey of hospitals participating in the UHC consortium
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127516
- Sponsor's protocol ID
- PT105051
- Status last verified
- Jul 2014
- First submitted
- 19 May 2010
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Causes and Interpretation of Low-level Resistance in Staphylococcus Aureus to Vancomycin Among a Network of Academic Medical Center Hospitals
- ClinicalTrials.gov ID
- NCT01127516
- Acronym / sponsor ID
- PT105051
- Conditions
- Staphylococcus Aureus
- Keywords
- Susceptibility testing, Antimicrobial stewardship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Apr 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this investigation is that rate of isolation of resistant nosocomial pathogens can be explained by a combination of measures that include, among other things, antimicrobial drug use, infection control efforts, patient mix and antimicrobial stewardship efforts. The short term goal of this investigation is to improve our understanding of the relationships between antimicrobial stewardship program efforts (and actual antimicrobial drug use), and infection control efforts to the incidence rates of MSSA, MRSA, h-VISA and SA-MICcreep. The long term goal of this investigation is to design interventions that will improve antimicrobial drug use and decrease cross-transmission of resistant bacteria, resulting in a decrease in the rates of infection caused resistant hospital organisms.
Detailed description
Study Design
We propose to survey clinical pharmacists, infectious diseases practitioners and clinical microbiologists at these 53 hospitals during the summer of 2009 to characterize the hospital policy toward isolation of SA-MICcreep and to investigate the relationship of SA-MICcreep to vancomycin use. Specifically, we will determine (1) if the hospital attempts to isolate SA-MICcreep (2) the method(s) of testing SA susceptibility to vancomycin, (3) interpretative criteria for MICs to vancomycin and whether there is a policy toward differential treatment of isolated with SA-MICcreep. In addition we will determine (1) the relationship of SA-MICcreep to vancomycin use and (2) the relationship to other hospital and patient demographics to SA-MICcreep. A pilot study (Dec. 2008) found that 7 of 8 hospitals surveyed do determine the vancomycin MIC for Staphylococcus aureus. However the interpretation of these findings, and the action taken, differ between hospitals. This may be because this is a newly described phenomenon, and professional organizations have not yet issued guidelines regarding the interpretation of these isolates (6).
We have measured vancomycin use by the following methods at each hospital:
- Days of therapy/1000 patient days.
- Mean duration of vancomycin therapy (days).
- Proportion of adult patients who receive vancomycin (%).
- Vancomycin "Intensity Index": The product of #2 and #3.
We will also measure the use of other antibacterial drugs that are used to treat infections caused by Staphylococcus aureus including linezolid and daptomycin as these drugs may reduce the isolation of SA-MICcreep.
The survey instrument will include requests for the following information:
- Does the clinical microbiology laboratory make an attempt to identify MIC creep for clinical isolates of Staphylococcus aureus?
- If yes, when did this policy begin?
- Are all Staphylococcus aureus isolates tested (i.e., MSSA and MRSA) or only MRSA?
- Are all clinical isolated routinely tested, or only selected isolates (e.g., only by request from ID, or only blood isolates, or only isolates from ICU patients, etc.)
- What method(s) is used to determine the MIC to vancomycin?
- What MIC is thought to warrant concern? (e.g., 1.0, 1.5, 2.0 mcg/ml) ?
- What action, if any, is taken as a function of the MIC to vancomycin?
- Is "more aggressive" therapy with vancomycin attempted if an isolate of concern is identified, or is alternative therapy recommended or routinely implemented?
- If alternative therapy is routinely administered, what is that therapy?
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients
Key inclusion criteria (1 listed)
- Adult inpatients
Key exclusion criteria (1 listed)
- Pediatric inpatients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of hospitals that test for MIC creep to vancomycin
Time frame: 2009
Survey of hospitals participating in the UHC consortium
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of hospitals that test for MIC creep to vancomycin (time frame: 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.